Roivant and Poxel Announce Strategic Agreement for Development and Commercialization of Imeglimin in the U.S., Europe, and Additional Countries Worldwide

Poxel to receive upfront payment of $35 million (approximately €28
million), potential future development and regulatory milestone
payments and sales-based payments of up to $600 million (approximately
€486 million), and double-digit royalties on net sales

Roivant to concurrently invest $15 million (approximately €12
million) in Poxel through subscription to newly-issued ordinary shares
at €8.5 per share

Poxel to contribute $25 million (approximately €20 million) to the
development program

Roivant will be responsible for imeglimin’s development and
commercialization in the U.S., Europe, and other countries outside of
Poxel’s partnership with Sumitomo Dainippon Pharma

Poxel to hold investor call today at 1 pm ET (7 pm CET)

BASEL, Switzerland & LYON, France--(BUSINESS WIRE)--
Roivant
Sciences, a global healthcare company focused on realizing the full
value of promising biomedical research, and POXEL
SA (Euronext: POXEL - FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
disorders including type 2 diabetes, today announced the signing of a
strategic development and license agreement for imeglimin, an
investigational oral therapy which has been developed by Poxel for the
potential treatment of type 2 diabetes, in the U.S., Europe, and all
other countries not covered by Poxel’s existing agreement in East and
Southeast Asia.1 This partnership enables Roivant to add an
innovative late-stage development program to its pipeline and Poxel
gains a strategic development and licensing agreement for imeglimin
beyond the company’s partnership with Sumitomo Dainippon Pharma.

Under the terms of the agreement, Poxel is entitled to receive an
upfront payment of $35 million (approximately €28 million) and Roivant
will invest $15 million (approximately €12 million) in Poxel through a
subscription to 1,431,399 newly-issued ordinary shares at €8.5 per
share. Poxel is entitled to receive potential future development and
regulatory milestone payments and sales-based payments of up to $600
million (approximately €486 million) subject to the successful clinical
development and commercialization of imeglimin. Furthermore, after
launch Poxel will be entitled to double-digit royalties on net sales.
Roivant will be responsible for development and commercialization costs
and Poxel will contribute $25 million (approximately €20 million) to the
development program. The parties will decide on a potential co-promotion
prior to commercialization.

“We are very pleased to partner with Roivant, an emerging leader in
biopharma with proven commitment to developing innovative therapies in
major disease areas. Roivant’s vision complements Poxel’s strategy of
bringing novel treatments for type 2 diabetes and other metabolic
disorders to patients,” said Thomas Kuhn, CEO of Poxel. “This is a
significant milestone for Poxel and for the development of imeglimin in
the U.S., Europe, and other countries outside of the Asian markets where
we have already partnered with Sumitomo Dainippon Pharma. The imeglimin
Phase 3 TIMES type 2 diabetes program in Japan is underway with a target
Japanese New Drug Application submission in 2020, and imeglimin is ready
to advance into late-stage development in the U.S. and Europe. 2018 will
be a transformative year for Poxel as we advance the TIMES program in
Japan, collaborate with Roivant on imeglimin, and increase our focus on
our earlier-stage pipeline.”

“We are pleased to have reached this agreement with Poxel as we continue
our strategy of in-licensing late-stage development candidates in
underserved therapeutic areas,” said Vivek Ramaswamy, Founder and CEO of
Roivant Sciences. “This agreement represents the beginning of our focus
on metabolic diseases and imeglimin, with its compelling and consistent
data, will be a cornerstone program. We are looking forward to rapidly
advancing its development.”

Activities in 2018 to support initiation of the Phase 3 program will
include differentiation studies to confirm imeglimin’s potential in
sensitive patient populations, such as those with chronic kidney
disease, as well as manufacturing of the drug product for use in the
Phase 3 program. The goal is to initiate the Phase 3 program in the U.S.
and Europe in 2019.

Imeglimin has completed Phase 1 and Phase 2 development in 18 clinical
studies involving over 1,200 subjects with type 2 diabetes in the U.S.,
Europe, and Japan, and met its primary and secondary endpoints,
including a statistically significant decrease of HbA1c and fasting
plasma glucose versus placebo, with a favorable side effect profile. For
more information about imeglimin clinical studies, please visit www.poxelpharma.com.

Poxel will host an investor conference call today to discuss this
partnership at 1 pm Eastern Time (7 pm Central European Time). To
participate in the call, please use the dial-in numbers below.

Imeglimin is the first clinical candidate in a new chemical class of
oral agents called the Glimins by the World Health Organization.
Imeglimin has a unique mechanism of action (MOA) that targets
mitochondrial bioenergetics and acts on the three key organs which play
an important role in the current anti-diabetic treatment paradigm: the
liver, muscles, and the pancreas2. Studies conducted to date
have suggested potential glucose lowering benefits through increased
insulin secretion in response to glucose3, improved insulin
sensitivity4, and suppression of gluconeogenesis2.
Imeglimin’s MOA also has the potential to prevent endothelial and
diastolic dysfunction5,6,7, and to provide protective effects
on beta-cell survival and function8. Poxel plans to publish
preclinical and clinical data on imeglimin and to present findings at
multiple scientific and medical congresses in 2018.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline
of drug candidates focused on the treatment of metabolic disorders,
including type 2 diabetes. We have successfully completed our Phase 2
clinical program for our first-in-class lead product, imeglimin, which
targets mitochondrial dysfunction, in the U.S., Europe and Japan, and
the Phase 3 Trials of IMeglimin for Efficacy
and Safety (TIMES) program in Japan is underway. Our second
program, PXL770, a direct adenosine monophosphate-activated protein
kinase (AMPK) activator, is completing Phase 1 development. Based on
this central metabolic role, targeting AMPK offers the opportunity to
pursue a wide range of indications to treat chronic metabolic diseases,
including diseases that affect the liver, such as non-alcoholic
steatohepatitis (NASH). We intend to generate further growth through
strategic partnerships and pipeline development. (Euronext: POXEL, www.poxelpharma.com)

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant
focuses on realizing the full potential of promising biomedical research
by developing and commercializing novel therapies across diverse
therapeutic areas. Roivant partners with innovative biopharmaceutical
companies and academic institutions to ensure that important medicines
are rapidly developed and delivered to patients.

Roivant advances its drug pipeline through wholly- or majority-owned
subsidiary companies, including Axovant (neurology), Myovant (women’s
health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare
diseases), and Urovant (urology). Roivant also pursues its mission by
incubating and launching innovative healthcare companies operating
outside of traditional biopharmaceutical development. Roivant’s
long-range mission is to reduce the time and cost of developing and
delivering new medicines for patients. For more information, please
visit www.roivant.com.

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